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Ultra-Pro II™ Needle Guide 610-1213, 610-1213-5

by Civco Medical Instruments Co., Inc.

Ref 610-917, 610-608

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841436101TD101A3NB Basic UDI-DI Date19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10841436103876 UDI-DI Date22 Aug 2017ListedStatusListed GUDID: 2 of 3 UDI-DIs in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-1892-2025 FDA Class II initiated 1 May 2025

    During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

    • Terminated Z-2888-2018 FDA Class II initiated 23 Feb 2018

    A cover failed leak testing during validation testing of new needle guides from a replacement tool.

  • 5 recalls, same reason

    • Terminated Z-0286-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0288-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0289-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0290-2016 FDA Class II initiated 21 Oct 2015
    • Terminated Z-0287-2016 FDA Class II initiated 21 Oct 2015

    Sterility of the product cannot be assured.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ultra-Pro II™ Needle Guide
Generic Name
Needle guide, single-use
Device Name
General Purpose Guidance – In-Plane, Fixed Angle (Ultra-Pro II guide)
Model / Ref / Catalog
610-917, 610-608, 610-1213, 610-1213-5, 610-936
Primary DI / UDI-DI
10841436103876, 10841436104439, 10841436102459
Basic UDI-DI
0841436101TD101A3NB
510(k) Number
FDA Product Code
ITX
EMDN Code
A018002 Needle guides
GMDN Term
Needle guide, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution (UDI-DI 10841436102459)
In Commercial Distribution (UDI-DI 10841436103876, 10841436104439)
Sterilization Method
Ethylene Oxide
Size
Length — 1.6 Inch
Height — 1.3 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K093713)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No